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Preparation method of transfer factor and preparation method of injection thereof

A technology of transfer factor and water for injection, which can be applied to medical preparations containing active ingredients, pharmaceutical formulations, peptide/protein components, etc. Safety, product quality assurance, and the effect of prolonging service life

Active Publication Date: 2015-05-27
武汉华龙生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The above-mentioned process method only uses centrifugation after freezing and thawing. On the one hand, it cannot fully and effectively remove various miscellaneous proteins, which makes the product prone to allergic reactions, and cannot effectively remove various animal-derived viruses, causing virus contamination and abnormal toxicity in the preparation. The risk of being qualified; on the other hand, the existing preparation methods all use microfiltration membranes and ultrafiltration membranes for filtration. The filtration membranes have a large load, short life, and high cost, which limits further medical use.
In the process of inactivation, add formaldehyde or carry out heating treatment. Formaldehyde is a carcinogen, and the residual free formaldehyde will produce an irritating reaction after being injected into the human body; heating will easily reduce the activity of transfer factor and affect the use effect
Amino acids and small peptides in injections tend to polymerize into macromolecular substances and precipitate out, resulting in unstable preparations and related side effects

Method used

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  • Preparation method of transfer factor and preparation method of injection thereof
  • Preparation method of transfer factor and preparation method of injection thereof
  • Preparation method of transfer factor and preparation method of injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation method of transfer factor comprises the following steps,

[0031] (1) Pretreatment: the pig spleen is stripped of its attached fat, washed twice with drinking water, and then washed three times with purified water;

[0032] (2) Homogenate: add water for injection 1.5 times the weight of pig spleen, mix, place in a colloid mill and grind repeatedly 4 times to make a homogenate, and store it at -16°C for more than 3 days;

[0033] (3) Repeated freezing and thawing: Take out the solidified homogenate and put it in a water bath at 33°C, stir continuously to make it melt quickly, and when the homogenate is completely melted into a liquid state, put it into a low-temperature freezer to freeze, repeat this 3 times ;

[0034] (4) Centrifugation: After thawing the homogenate, centrifuge at 4°C and 3000r / min for 30 minutes, and take the homogenate supernatant;

[0035] (5) Ethanol precipitation: Add absolute ethanol to the homogenate supernatant at a volume rati...

Embodiment 2

[0042] The preparation method of transfer factor comprises the following steps,

[0043] (1) Pretreatment: the pig spleen is stripped of its attached fat, washed twice with drinking water, and then washed three times with purified water;

[0044] (2) Homogenate: add water for injection twice the weight of pig spleen, mix, place in a colloid mill and grind repeatedly 6 times to make a homogenate, and store it at -16°C for more than 3 days;

[0045] (3) Repeated freezing and thawing: Take out the solidified homogenate and put it in a water bath at 35°C, and stir it continuously to make it melt quickly. ;

[0046] (4) Centrifugation: After thawing the homogenate, centrifuge at 4°C and 3000r / min for 30 minutes, and take the homogenate supernatant;

[0047] (5) Ethanol precipitation: Add absolute ethanol to the homogenate supernatant at a volume ratio of 1:2 under constant stirring, let it stand at 0°C for more than 12 hours, centrifuge at 4°C at a speed of 3000r / min for 30 minut...

Embodiment 3

[0054] The preparation method of transfer factor comprises the following steps,

[0055] (1) Pretreatment: the pig spleen is stripped of its attached fat, washed twice with drinking water, and then washed three times with purified water;

[0056] (2) Homogenate: add water for injection 1.8 times the weight of pig spleen, mix, place in a colloid mill and grind repeatedly 5 times to make a homogenate, and store it at -16°C for more than 3 days;

[0057] (3) Repeated freezing and thawing: Take out the solidified homogenate and put it in a water bath at 33°C, stir continuously to make it melt quickly, and when the homogenate is completely melted into a liquid state, put it into a low-temperature freezer to freeze, repeat this 3 times ;

[0058] (4) Centrifugation: After thawing the homogenate, centrifuge at 4°C and 3000r / min for 30 minutes, and take the homogenate supernatant;

[0059] (5) Ethanol precipitation: Add absolute ethanol to the homogenate supernatant at a volume rati...

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Abstract

The invention discloses a preparation method of a transfer factor. The preparation method of the transfer factor is characterized by comprising the steps: pre-processing, homogenation, repeated freeze thawing, centrifugation, ethanol precipitation, primary ultra-filtration, virus inactivation and secondary ultra-filtration. The invention also discloses a preparation method of a transfer factor injection. According to an ethanol precipitation method and a virus deactivation method which are not adopted in a traditional process, various impurity proteins are removed, and various animal source viruses are effectively removed, so that the security of products can be effectively guaranteed, sensitive sources are reduced, and the security is improved; meanwhile, by adopting an ethanol precipitation method, the impurity proteins are removed, so that the ultra-filtration load of a subsequent ultrafiltration membrane can be reduced, and the service life of the ultrafiltration membrane is prolonged.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a method for preparing transfer factor and a method for preparing an injection thereof. Background technique [0002] Transfer Factor (TF), also known as transfer factor, is produced by lymphocytes with cellular immune function, and is a dialyzable factor obtained from freeze-thawed sensitized T cells. It can strengthen the immunity of animals, and can transfer the ability of delayed allergic reaction from one individual (including humans and animals) to another individual, and they transport the antigen-specific cellular immunity (delayed allergic reaction) of parent lymphocytes to unexposed or primary lymphocytes. Transfer factor carries the specific immune information of sensitized lymphocytes, and can present specific immune information to recipient lymphocytes, so that recipient inactive lymphocytes can be transformed into specific sensitized lymphocytes, thereby stimulati...

Claims

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Application Information

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IPC IPC(8): A61K35/26A61K38/00A61K9/08A61P37/04
Inventor 黄楚华王世民戴军宝
Owner 武汉华龙生物制药有限公司
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